"When a patient comes in and wants something, there is a desire to serve them," said Wofsy, of the American College of Rheumatology. "There is a desire on the part of physicians, as there is on anyone else who provides service, to keep the customer happy."
The COX-2 drugs caught fire. Current annual sales in the United States total $5.6 billion. In 2003, Vioxx alone represented 11 percent of the revenue for Merck, the fourth-largest drug company by sales in the United States.
| | | | | | | | | | _____Questions & Answers_____
• What should I do if I take Vioxx? Contact your doctor to discuss how best to discontinue the drug and find alternative treatment.
• What are the long-term effects of taking Vioxx? A new study shows the drug may cause an increased risk of heart attack and strokes, though the FDA says such risk is small.
• Can I get my prescription filled for Vioxx? No, Merck is withdrawing the drug from all pharmacies in the United States.
• What should I do with my Vioxx pills? Keep them. Merck is reimbursing patients for unused medication. Visit www.vioxx.com to find out how to file a claim.
• How can I report serious side effects to the FDA? Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
• How important is Vioxx to its manufacturer? It's been one of Merck's most important drugs, with $2.5 billion in sales in 2003 -- about 11 percent of the company's revenue.
• How will the recall affect Merck stockholders? Merck says it expects earnings per share to fall by as much as 60 cents in the fourth quarter.
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_____From Merck_____
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Release Announcing Vioxx Withdrawal (PDF)
_____The Heart_____
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Vioxx's Removal May Not Affect Care Much (The Washington Post, Oct 1, 2004)
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Merck Withdraws Arthritis Medication (The Washington Post, Oct 1, 2004)
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Merck Withdraws Arthritis Drug Vioxx (The Washington Post, Sep 30, 2004)
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A Weekly Shot of News and Notes (The Washington Post, Sep 28, 2004)
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Wasabi as Decongestant? Just Say Nose (The Washington Post, Sep 28, 2004)
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More Heart News
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What is particularly ironic about this past week's events is that they came as aspirin, the hoary ancestor of both the nonsteroidal and the COX-2 drugs, continues to be reborn as something close to a miracle drug.
Synthesized in 1897 by the German chemist Felix Hoffmann as a pain-reliever for his arthritic father, aspirin since then has been found to lower the risk of heart attack in people with heart disease, and possibly to lower the risk of colon, prostate and breast cancer, Hodgkin's disease and Alzheimer's.
Although the reason Vioxx caused heart problems is not certain, researchers believe its selective action on the COX-2 enzyme, but not the COX-1, throws the prostanoids involved in clotting out of balance.
The result is a tendency for blood to clot -- and clots are the first step of heart attacks and most strokes. If that theory is correct, it means that Vioxx's cleverness was also its Achilles' heel.
The experience of "targeted" drugs -- the goal of most pharmaceutical research today -- has been mixed. While some have been huge successes -- the statins that lower cholesterol by inhibiting a single enzyme -- others have been disappointing. In particular, numerous new "biological modifier" anti-cancer drugs (such as those that try to stop the growth of blood vessels in tumors) have failed to live up to their promise. They are clever, but not as clever as the body's ability to find a way around them.
In the end, the Vioxx debacle suggests that figuring the true worth of new drugs may be a more difficult calculation than it seems.
Patients and doctors are left wondering if a drug is worth trying simply because it is new and supposedly a little bit better than what they are already using.
Companies such as Merck may wonder whether it is wise not to address directly early hints that there are problems with their golden goose products.
American society may also wonder whether expensive new drugs such as Vioxx -- part pharmaceutical, part fetish object -- are worth the money.
Avorn, who in August published a book, "Powerful Medicine: The Benefits, Risks, and Costs of Prescription Drugs," thinks the answer generally is no.
The use of Vioxx by people who did not need the modest amount of stomach protection it offered "has cost billions of dollars that could have been better used for other purposes in our health care system," he said. "There is this newer-is-better mentality, and this is why we can't afford health care."
